WO2001097715A1 - Systeme d'apport - Google Patents

Systeme d'apport Download PDF

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Publication number
WO2001097715A1
WO2001097715A1 PCT/EP2001/006631 EP0106631W WO0197715A1 WO 2001097715 A1 WO2001097715 A1 WO 2001097715A1 EP 0106631 W EP0106631 W EP 0106631W WO 0197715 A1 WO0197715 A1 WO 0197715A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
catheter
balloon
stent
delivery system
Prior art date
Application number
PCT/EP2001/006631
Other languages
English (en)
Inventor
Jan Otto Solem
Original Assignee
Jan Otto Solem
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jan Otto Solem filed Critical Jan Otto Solem
Priority to EP01938259A priority Critical patent/EP1292245B1/fr
Priority to DE60112573T priority patent/DE60112573T2/de
Priority to CA002413849A priority patent/CA2413849A1/fr
Priority to AT01938259T priority patent/ATE301443T1/de
Priority to JP2002503193A priority patent/JP2003535642A/ja
Priority to AU2001263958A priority patent/AU2001263958A1/en
Publication of WO2001097715A1 publication Critical patent/WO2001097715A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable

Definitions

  • the present invention is related to a delivery system for self-expanding medical vascular devices.
  • Modern treatment of vascular blockage like arteriosclerosis in arteries or other abnormalities in anatomical ducts or vessels that create blockings or narrowing in the ducts today more often comprises balloon dilatation and securing the inner vessel wall by means of metal grid cylinders, so called stents, to prevent collapse of the vessel walls after the dilatation.
  • stents In other cases where there is a lesion in the duct wall causing bleeding or a risk of bleeding, covered stents or stented vascular grafts may secure such lesions. Extremely important is the closure of such leaks in the vessels of the brain and the heart.
  • Stents are also used to keep other ducts open in the body (e.g. the oesophagus, the bile ducts and the airway passages) that are suffering of blockages due to causes like cancer.
  • stents that have to be expanded by means of a balloon, i.e. ' pressure-expandable stents, and then the flexible self-expanding stents made of memory metals like the Nitinol stents, that will expand by themselves as a result of the inherent inner strength and memory.
  • the self-expanding memory metal stents have the advantage of taking the form and size of the vessel even some time after its placement and it remains flexible.
  • the drawbacks of self-expanding stents and covered stents and covered stent grafts include the difficulty to deploy them. They will have to be restrained inside cylinders during the placement and thereafter pushed out of the restraining cylinders when the desired point is reached.
  • the restraining cylinders and the pushing rods make the whole system bulky and stiff and thereby not suitable for small vessels and vessels on locations where the vessels are tortuous, like in the brain and in the heart.
  • US-A-5 549 635 discloses a deployment apparatus for a self-expanding stent which uses a catheter, a balloon enclosing a distal part of the catheter, a self-expanding stent enclosing the balloon and two breakable retainer rings enclosing distal and proximal end portions of the self-expanding stent in a compressed state thereof.
  • the retainer rings When inflating the balloon the retainer rings will get loose from the self-expanding stent which will expand. Then the catheter including the balloon and the breakable retainer rings should be withdrawn through the now expanded stent.
  • a main object of the present invention is to provide a stent delivery system and method which allow deploying of a self expanding stent also in ducts of relatively small diameters and following curved paths such that very bendable and flexible stents may be deployed.
  • a stent delivery system according to claim 1, a stent delivery capsule device for introduction into a vessel by means of a catheter according to claim 11 and a method of inserting a self expandable stent device into an anatomical duct according to claim 14.
  • a stent delivery system comprises a catheter having a distal end and a proximal end, and a self expanding stent device having a compressed state and an expanded state and being positioned along the catheter and close to the distal end thereof.
  • the stent delivery system further comprises a capsule enclosing the self expanding stent device in its compressed state along substantially the whole length thereof, said capsule having an open distal end and a proximal end fixed to the catheter and further having at least one perforation extending longitudinally of said capsule from the distal end substantially to the proximal end thereof.
  • the stent delivery system comprises a balloon positioned within the capsule so as to break the capsule along said at least one perforation.
  • the stent device may expand to its expanded state and the catheter with the broken capsule may be withdrawn.
  • the balloon encloses a distal part of the catheter and the stent device encloses the balloon.
  • the balloon encloses a distal part of the catheter and the stent device is positioned between the balloon and the capsule in a circumferentially limited area.
  • the balloon is positioned between the catheter and the capsule in a first, circumferentially limited area and the stent device is positioned between the catheter and the capsule in a second, circumferentially limited area.
  • the capsule is positioned outside the perimeter of the catheter. Then, the stent device and the balloon are preferably positioned side by side in the capsule. Alternatively, the balloon may be positioned within the stent device.
  • a stent delivery capsule device for introduction into a vessel by means of a catheter comprises a substantially cylindrical capsule having an open distal end and a closed proximal end, a self expanding stent device and a balloon, both positioned within the capsule and extending substantially along the length thereof.
  • a method of inserting a self expandable stent device into an anatomical duct comprises the steps of i) providing a stent delivery system which comprises: a catheter having a distal end and a proximal end, a self expanding stent device having a compressed state and an expanded state and being positioned along the catheter and close to the distal end thereof, and a capsule enclosing the self expanding stent device in its compressed state along substantially the whole length thereof .
  • the capsule has an open distal end and a proximal end fixed to the catheter and further has at least one perforation extending longitudinally of said capsule from the distal end substantially to the proximal end thereof, and a balloon positioned within the capsule and capable of breaking the capsule along said at least one perforation when expanded; ii) inserting the catheter to which the capsule is fixed, into said anatomical duct and to a desired position therein; iii) inflating the balloon such that the capsule is ruptured and the stent device is expanded to its expanded state engaging an inner surface of the duct; and iv) withdrawing the catheter and the capsule fixed thereto from said desired position in the duct, whereby the stent device is deployed at the desired position in the duct .
  • the delivery system according to the invention can be made with small diameters.
  • the system permits a more precise placement of the stent in the vessel than the prior systems relying on release from the system by pushing or movement in the axial direction of the catheter.
  • the delivery system according to the invention is also advantageous as compared to the delivery system of US-A-5 549 635 in that it has a high flexibility and is soft so that it may enter tortuous vessels without damaging the vessel wall.
  • self- expanding devices with a great variety of forms may be used. Thereby tailored special devices having branches, ends sticking out, umbrella shape and any other shape may be restrained within the capsule during delivery. Further, the capsule may be produced together with the device as an integrated part thereof and later assembled to the catheter.
  • Fig. 1 is a longitudinal sectional view of a first embodiment of a stent delivery system according to the - present invention.
  • Fig. 2 is a cross-sectional view along the line II- II in Fig. 1.
  • Fig. 3 is an elevational view of a capsule shown in Fig. 1.
  • Fig. 4 is an elevational view of the capsule in Fig. 3 when ruptured.
  • Fig. 5 is an elevational view of an alternative embodiment of the capsule shown in Fig. 3
  • Fig. 6 is an elevational view of the capsule in Fig. 5 when ruptured.
  • Fig. 7 is a longitudinal sectional view of a second embodiment of a stent delivery system according to the present invention.
  • Fig. 8 is a cross-sectional view along the line VIII-VIII in Fig. 7.
  • Fig. 9 is a longitudinal sectional view of a third embodiment of a stent delivery system according to the present invention.
  • Fig. 10 is a cross-sectional view along the line X-X in Fig. 9.
  • Fig. 11 is a cross-sectional view along the line XI- XI in Fig. 9.
  • Figs 12-16 are cross-sectional views illustrating five different embodiments of a stent delivery system according to the present invention (Figs 12, 13 and 14 being identical to Figs 2, 8 and 10, respectively) .
  • Figs 17-19 illustrate the deployment of the first embodiment of a stent delivery system according to the present invention.
  • Figs 20 and 21 illustrate the deployment of the second embodiment of a stent delivery system according to the present invention.
  • Figs 22 and 23 illustrate the deployment of the third embodiment of a stent delivery system according to the present invention.
  • a first embodiment of a stent delivery system comprises a cardiac catheterisation catheter 1 or any other vascular interventional catheter with a balloon 2 enclosing a distal part of the catheter 1.
  • the catheter 1 has a separate lumen 3 extending from the proximal end of the balloon 2 to the proximal end of the catheter 1. This lumen 3 is used for inflating and deflating the balloon 2 which is shown in its deflated state in Fig. 1.
  • a self expanding stent device 4 e.g. a stent, a covered stent or a stent graft, is positioned on and substantially enclosing the balloon 2. It is held in a compressed state by an enclosing tube or capsule 5.
  • this capsule 5 is a cylinder preferably made of a synthetic, plastic material, e.g. expanded polytetrafluoroethylen (PTFE) , polyvinyl , polyurethan or any other synthetic material.
  • PTFE polytetrafluoroethylen
  • a proximal end part 6 of the capsule 5 is a ring of reduced diameter so as to fit tightly on the interventional catheter 1 and thus being fixed thereto.
  • a most important feature of this capsule 5 is a longitudinal perforation line 7 that will result in a fracture of the wall of the capsule 5 when the balloon 2 is inflated to release the self expanding stent device 4 inside the capsule 5.
  • the capsule 5 will transform from its state (Fig. 3) keeping the stent 4 compressed to its ruptured state (Fig. 4) being split into two strips along its length from the distal end thereof to the non-ruptured ring 6 thereof at the proximal end of the capsule 4.
  • the capsule 5 may have a single perforation line 7, two perforation lines 7, as shown in Figs 3 and 4, or a multiple perforation lines 7, as illustrated by a second embodiment of the capsule in Figs 5 and 6.
  • the ruptured capsule i.e. after inflation of the balloon, will have different shapes with one or more stripes of material extending from a non-ruptured proximal end 6 of the capsule 5 to the open distal end of the capsule 5.
  • the capsule 5 may be fixed on the interventional catheter 1 outside of the balloon 2 by gluing the narrow proximal end part 6 to the perimeter of the catheter 1 at a position proximal of the balloon 2.
  • a second embodiment of the delivery system has a self-expanding stent 8 positioned outside the catheter 1 and the balloon 2 but still inside a capsule 9 which keeps the stent 8 in its compressed state.
  • the capsule 9 defines a pocket 10 outside the catheter 1, and the balloon 2 lies within a circumferentially limited area.
  • the capsule 9 may have a single perforation line 7 located on its top and/or perforation lines 7 located on its sides, as seen in Fig. 8.
  • a third embodiment of the delivery system has a capsule il which does not enclose the interventional catheter 1 but is positioned outside and along the interventional catheter 1.
  • This capsule 11 may have a smaller diameter than the capsule 5 and 9 according to the first and second embodiments, respectively, as it is not depending of the dimension of the catheter 1. Thus, this capsule 11 sits on top of the interventional catheter 1 like a backpack. In this configuration the interventional catheter 1 does not have any balloon since a balloon 12 is located within the capsule 11 itself.
  • This smaller balloon 12 has its own small lumen 13 connected to the proximal end of the catheter 1 and running through (as shown in Figs 9 and 11) or on the outside of the interventional catheter 1 for inflation and deflation of the small deployment balloon 12 inside the capsule 11.
  • a stent, covered stent or a covered stent graft 14 is inserted inside the small capsule 11 side by side with the balloon 12, i.e. between the capsule wall and the balloon 12 inside the capsule
  • Figs 12-16 schematically depict a summary of five different embodiments of the deliver system according to the present invention.
  • the embodiments in. Figs 12, 13 and 14 correspond to the first , second and third embodiments , as is evident from a comparison with Figs 2, 8 and 10, respectively.
  • a stent 15 and a balloon 16 are positioned outside the catheter 1 and inside a capsule 17, each one in a circumferentially limited area within a pocket 18, 19 defined by the capsule 17.
  • the two pockets 18, 19 may be positioned apart from each other circumferentially or close together so as to form a single pocket.
  • a capsule 11 is positioned outside the catheter 1, as in the above- described third embodiment, and encloses both a stent 20 and a small deployment balloon 21.
  • the balloon 21 is positioned inside the stent 20 enabling the use of either a self-expanding stent or a pressure-expanded stent.
  • the catheter 1 is placed inside the wall of a vessel 22 at the intended location for the deployment of the self-expanding device 4, cf . Fig. 17. Then the balloon 2 is inflated such that the capsule 5 will open along the perforation lines 7 and the stent 4 will expand to engagement with the vessel wall at the correct position, cf. Fig. 18. There are now two small remaining strips 23 of the capsule present between the vessel wall and the stent 4. Now, the balloon 2 is deflated and the catheter 1 is retracted. The two strips 23 are only a fraction of the size of the expanded stent 4 and shorter than the stent 4 and will easily follow the catheter 1 out when this is retracted in the direction of an arrow A, cf . Fig. 19. Referring to Figs 20-21, a method of inserting a self-expandable stent using the second embodiment will be described.
  • Fig. 20 the second embodiment, illustrated in Fig. 7, is shown introduced into a vessel 22 and with the balloon 2 inflated. Consequently, the capsule 9 has broken along the two perforation lines 7 at the side of the balloon 2. Thus, the capsule 9 is open and the stent
  • Fig. 22 the third embodiment, illustrated in Figs 9-11, is shown introduced into a vessel 22 and with the balloon 12 inflated. Consequently, the capsule 11 has broken along the single perforation line 7 at the top of the capsule 11.
  • the capsule 11 is open and the stent 14 is positioned at correct position in the vessel 22.
  • the stent 14 will expand partially and press the catheter 1 with the capsule 11 against the vessel wall.
  • the stent 14 will not expand completely until the balloon 12 is deflated and the catheter 1 withdrawn.
  • the catheter 1 and the opened capsule 11 are retracted out of the vessel .
  • the remaining strip 25 of the capsule 11 will follow the catheter 1 when this is retracted in the direction of an arrow A, as showed in Fig.
  • the self- expanding device is restrained inside a soft, flexible capsule located outside of a catheter as a backpack or around a catheter.
  • the capsule has the special feature of a perforation line. By inflating a balloon the perforation line is broken and the device is deployed and may expand.
  • the distal ends of the catheter, the balloon, the stent device and the capsule may be bifurcated so as to fit into a bifurcation of a vessel.
  • the stent may be divided into several longitudinally separated sections.

Abstract

L'invention concerne un système d'apport d'endoprothèse, qui comprend un cathéter (1) présentant une extrémité distale et une extrémité proximale, et un dispositif d'endoprothèse (4; 8; 14; 15; 20) auto-expansible présentant un état comprimé et un état étendu, qui se place le long du cathéter (1) à proximité de l'extrémité distale de celui-ci. Le système d'apport d'endoprothèse comporte de plus une capsule (5; 9; 11; 17) contenant le dispositif d'endoprothèse (4; 8; 14; 15; 20) auto-expansible, à l'état comprimé, sur sensiblement toute la longueur de celle-ci. La capsule (5; 9; 11; 17) présente une extrémité distale ouverte et une extrémité proximale fixée au cathéter (1). De plus, la capsule (5; 9; 11; 17) comporte au moins une perforation (7) s'étendant dans le sens longitudinal de la capsule (5; 9; 11; 17) depuis l'extrémité distale vers l'extrémité proximale. Le système d'apport d'endoprothèse comporte aussi un ballonnet (2; 12; 16; 21) placé dans la capsule (5; 9; 11; 17) de manière à rompre la capsule (5; 9; 11; 17) le long de la ou des perforations (7) quand il est gonflé, permettant au dispositif d'endoprothèse (4; 8; 14; 15; 20) de s'étendre. Ensuite le cathéter (1) avec la capsule (5; 9; 11; 17) rompue peut être retiré d'un conduit (22) dans lequel le cathéter (1) a été introduit dans une position voulue.
PCT/EP2001/006631 2000-06-22 2001-06-11 Systeme d'apport WO2001097715A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
EP01938259A EP1292245B1 (fr) 2000-06-22 2001-06-11 Systeme d'apport
DE60112573T DE60112573T2 (de) 2000-06-22 2001-06-11 Verabreichungsanordnung
CA002413849A CA2413849A1 (fr) 2000-06-22 2001-06-11 Systeme d'apport
AT01938259T ATE301443T1 (de) 2000-06-22 2001-06-11 Verabreichungsanordnung
JP2002503193A JP2003535642A (ja) 2000-06-22 2001-06-11 送出システム
AU2001263958A AU2001263958A1 (en) 2000-06-22 2001-06-11 Delivery system

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE0002395A SE522805C2 (sv) 2000-06-22 2000-06-22 Stentappliceringssystem
SE0002395-2 2000-06-22

Publications (1)

Publication Number Publication Date
WO2001097715A1 true WO2001097715A1 (fr) 2001-12-27

Family

ID=20280247

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2001/006631 WO2001097715A1 (fr) 2000-06-22 2001-06-11 Systeme d'apport

Country Status (9)

Country Link
US (1) US6656213B2 (fr)
EP (1) EP1292245B1 (fr)
JP (1) JP2003535642A (fr)
AT (1) ATE301443T1 (fr)
AU (1) AU2001263958A1 (fr)
CA (1) CA2413849A1 (fr)
DE (1) DE60112573T2 (fr)
SE (1) SE522805C2 (fr)
WO (1) WO2001097715A1 (fr)

Cited By (81)

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WO2006004825A2 (fr) * 2004-06-30 2006-01-12 Edwards Lifesciences Pvt, Inc. Dispositif et procede pour faciliter l'implantation d'une prothese de valve
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EP1679095A1 (fr) * 2003-10-15 2006-07-12 Kabushikikaisha Igaki Iryo Sekkei Dispositif de mise en place de stent
WO2007011730A1 (fr) * 2005-07-14 2007-01-25 Cappella Inc. Systeme d'apport et procede d'utilisation pour deployer un dispositif vasculaire auto-extensible
WO2008121380A1 (fr) * 2007-03-31 2008-10-09 Cook Incorporated Système de délivrance de dispositif médical muni d'une séparation de gaine
WO2008157830A1 (fr) * 2007-06-21 2008-12-24 Cappella, Inc. Système de mise en place d'appareil médical avec gaine et position relative du ballon
WO2009009636A1 (fr) * 2007-07-10 2009-01-15 Boston Scientific Limited Dispositif de protection d'endoprothèse à double conicité
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WO2011094048A1 (fr) * 2010-01-27 2011-08-04 Abbott Laboratories Ensemble à double gaine et procédé d'utilisation
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EP1292245B1 (fr) 2005-08-10
DE60112573T2 (de) 2006-05-18
SE0002395D0 (sv) 2000-06-22
ATE301443T1 (de) 2005-08-15
US20010056295A1 (en) 2001-12-27
AU2001263958A1 (en) 2002-01-02
CA2413849A1 (fr) 2001-12-27
EP1292245A1 (fr) 2003-03-19
SE522805C2 (sv) 2004-03-09
SE0002395L (sv) 2001-12-23
US6656213B2 (en) 2003-12-02
JP2003535642A (ja) 2003-12-02
DE60112573D1 (de) 2005-09-15

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